Esomeprazole Magnesium Delayed-Release 20 mg (OTC)

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Esomeprazole Magnesium Delayed-Release 20 mg (OTC)
Generic name: ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG (OTC)
Manufacturer: MARKSANS PHARMA LIMITED
Product type: HUMAN OTC DRUG
SPL set ID: 6a21f085-b60b-49b7-8098-99ccdc43dde3
SPL ID: f2f3282e-c6de-42ea-9a6f-d6b573256968
Version: 3
Effective date: 2026-06-01
Source export date: 2026-11-06
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:48:39

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	217264	derived:openfda.application_number
application number		ANDA217264	openfda.application_number
brand name		Esomeprazole Magnesium Delayed-Release 20 mg (OTC)	openfda.brand_name
brand name		Esomeprazole Magnesium Delayed Release 20 mg mini	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG (OTC)	openfda.generic_name
generic name		ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE 20 MG MINI	openfda.generic_name
manufacturer name		MARKSANS PHARMA LIMITED	openfda.manufacturer_name
ndc	package	25000-088-76	openfda.package_ndc
ndc	package	25000-096-76	openfda.package_ndc
ndc	product	25000-096	openfda.product_ndc
ndc	product	25000-088	openfda.product_ndc
ndc11	package	25000008876	derived:openfda.package_ndc
ndc11	package	25000009676	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		f2f3282e-c6de-42ea-9a6f-d6b573256968	id
spl set id		6a21f085-b60b-49b7-8098-99ccdc43dde3	set_id
unii		R6DXU4WAY9	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Allergy alert: Do not use if you are allergic to esomeprazole Esomeprazole may cause severe skin reactions. Symptoms include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical attention right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.